Johnson & Johnson Pharmaceutical Research says FDA's paliperidone meeting cancelled

By Elaine Rigoli

Tampa, Fla., July 21 - The Food and Drug Administration's psychopharmacologic drugs advisory committee has cancelled the Sept. 7 review meeting for Johnson & Johnson Pharmaceutical Research and Development, LLC's New Drug Application for paliperidone extended-release.

The cancellation came at the request of the Division of Psychiatry Products after communicating it had not identified any issues requiring advisory committee feedback, according to a news release.

The company said paliperidone, a new chemical entity, is the first and only atypical antipsychotic to use the OROS extended-release technology, a continuous release of medication over a 24-hour period, leading to minimal peaks and troughs in plasma concentrations.

Moreover, paliperidone is not extensively metabolized by the liver and is excreted largely unchanged through the kidney.

The paliperidone extended-release filing is based on an extensive global clinical development program that involved more than 1,600 patients in 23 countries.

Johnson & Johnson Pharmaceutical Research and Development is based in Raritan, N.J.

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